Alex Delaney-Gesing 

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Mary Elizabeth Hartnett, MD, FACS, FARVO,

 a distinguished professor in Ophthalmology and Visual Sciences, University of Utah, as well as director of Pediatric Retina at the John A. Moran Eye Center, and 

 a vitreous and retinal surgeon at the Wilmer Eye Institute, Johns Hopkins University, analyze two areas of 

relevant to today's field:

Dr. Hartnett highlights current research being conducted on the pathophysiology of AMD involving very long chain polyunsaturated fatty acids and new mechanism for fibrosis and neovascular AMD. 

Dr. Breazzano discusses how the COVID-19 pandemic has altered how ophthalmologists treat wet AMD, and how physicians can maximize their patient outcomes. 

Podcasts

Mary Elizabeth Hartnett, MD, FACS, FARVO, and Mark Breazzano, MD, discuss current research being conducted involving AMD and maximizing patient outcomes amid the pandemic. 

Analyzing AMD in research, COVID-19-era practice

Bausch + Lomb and Novaliq GmbH have announced statistically significant topline data from the first phase 3 trial (GOBI trial) analyzing the investigational drug NOV03 as a first-in-class eye drop to treat dry eye disease (DED) associated with meibomian gland dysfunction (MGD).

The GOBI trial included 597 participants — aged 18 years and older — who randomly received either treatment with NOV03 four times a day or were administered a placebo (saline solution) four times a day, 

Conducted at 26 locations around the U.S., the double-masked, saline-controlled study also included four pre-specified secondary endpoints, which all demonstrated statistical superiority over the placebo.

The GOBI trial also met both of its co-primary, according to a company news release. This included:

A change from baseline in total corneal fluorescein staining (tCFS) that achieved statistical significance at day 15 [p-value = 0.001] (secondary endpoint), with continued results through day 57 (primary endpoint) compared to control [p-value < 0.001]


A change from baseline in dryness score that achieved statistical significance at day 15 [p-value = 0.009] (secondary endpoint), with continued results through day 57 (primary endpoint) compared to control [p-value < 0.001], as rated on a visual analogue scale (VAS) ranging from 0-100 (0 = no discomfort; 100 = maximum discomfort).


Overall, NOV03 was well-tolerated, with instillation site reactions below 0.5%, the release reported. Treatment emergent adverse events (TEAEs) were not reported by more than 3% of participants in either treatment group.

The number of patients who also reported at least one ocular TEAE was close between the treatment control arms, respectively.

With no current pharmaceutical therapy available in the U.S. for the treatment of DED associated with MGD, the latest topline results are encouraging, said Yolande Barnard, vice president and general manager, U.S. Pharmaceuticals at Bausch + Lomb, in the news release.

“These outstanding topline results are very encouraging that we may be able to bring this first-in-class treatment option to market for the millions of patients who have dry eye disease associated with meibomian gland dysfunction,” Barnard said.

Novaliq CEO Christian Roesky, PhD, expressed similar thoughts on the study’s results.

“We are very pleased with both the robustness and consistency of the results demonstrated in the GOBI trial as they confirm all efficacy and safety results from the previous Phase 2 SEECASE trial,” he said in a statement.

The trial program also includes an ongoing second phase 3, multi-center, randomized, double-masked saline-controlled trial (MOJAVE study), as well as a multi-center, single-arm 12-month safety extension trial (KALAHARI study).

If positive, topline results from the MOJAVE study would allow for a filing to the U.S. FDA in 2022.

1. Bausch + Lomb. Bausch + Lomb announces statistically significant topline results from the first phase 3 trial of NOV03 (perfluorohexyloctane) in dry eye disease associated with meibomian gland dysfunction. Available at: 

https://www.bausch.com/our-company/recent-news/artmid/11336/articleid/665/04132021-tuesday

Articles

Bausch + Lomb and Novaliq GmbH have announced statistically significant topline data from the first phase 3 trial analyzing the investigational drug NOV03 as a first-in-class eye drop to treat dry eye disease associated with MGD.

Bausch + Lomb announces topline results for phase III trial of NOV03 to treat DED associated with MGD


Peter J. Polack, MD, FACS, and Zora Harrison, COO at Ocala Eye in North Central Florida, share the protocols and technology their practice implemented throughout the pandemic that has enabled them to safely and efficiently treat their patients.

COVID-19: Year in the life of ophthalmology practice

Find out how one eye care practice has found success in adapting their services to ensure staff/patient safety throughout the pandemic. 

Adjusting ophthalmology practice to a pandemic 

A diminishment of both hearing and vision is linked to an increased risk for dementia and mental decline, according to a new study.

, the South Korean study found that having just one of the two impairments is not connected with a higher risk.

The study consisted of 6,520 participants between ages 58 and 101, with visual and hearing impairments assessed by a questionnaire asking about their use of glasses or hearing aids.

Of those individuals, 932 people reported having both normal vision and hearing, 2,957 claimed either visual or hearing issues, and 2,631 said they had both impairments.

At the beginning of the study, dementia was more than twice as common in the group with both impairments. From that, 8% had the disease at the start, compared to 2.4% in the group with one sensory impairment and 2.3% with no sensory impairment.

Participants’ thinking and memory skills were evaluated every 2 years for 6 years via a wood recall and recognition test. Researchers then assessed the relationship between having one sensory impairment and dementia, as well as having both impairments and dementia.

Throughout this 6-year follow-up period, 245 participants developed dementia.

Further, from the 1,964 individuals with both hearing and vision impairment: 146 developed dementia; 69 of the 2,397 individuals with one impairment developed dementia; 14 of the 737 individuals with no impairments developed dementia; and 16 out of the 142 individuals who could not determine if they had a sensory impairment also developed dementia.

Upon adjustment for various factors — sex, education, income — investigators discovered the group with both hearing and vision impairments were twice as likely to develop dementia compared to the group with normal hearing and vision. Participants with only one impairment were found to be no more likely to develop dementia as the group with normal sensory function.

Further, the decrease in scoring on the thinking test was higher among those with both a hearing and vision impairment. 

While it is not apparent why a decline in both senses — not just one — may raise the risk for dementia, investigators theorized the importance of socialization as being key to a mentally sharp mind.

"Older people with only a visual or hearing impairment can usually still maintain social contact, so they may not feel as isolated or depressed as people who have both impairments," said Dr. Jin Hyeong Jhoo of Kangwon National University School of Medicine in Chuncheon, South Korea, 

in an American Academy of Neurology article.

However, Dr. Jhoo further explained, when an individual has both impairments, their risk of isolation and depression may also increase.

Jhoo stated that additional research would be needed to explain why those with two impairments are at a greater risk for developing dementia than those with just one impairment.

To note, a drawback of this study included the self-reports of participants on the distributed questionnaire.

1. Gihwan B, Gyu han Oh, Jin Hyeong Jhoo, Jae-Won Jang, Jong Bin Bae, Ji Won Han, Tae Hui Kim, Kyung Phil Kwak, Bong Jo Kim, Shin Gyeom Kim, Jeong Lan Kim, Seok Woo Moon, Joon Hyuk Park, Seung-Ho Ryu, Jong Chul Youn, Dong Woo Lee, Seok Bum Lee, Jung Jae Lee, Dong Young Lee, Ki Woong Kim. Dual Sensory Impairment and Cognitive Impairment in the Korean Longitudinal Elderly Cohort. 

 Apr 2021, 10.1212/WNL.0000000000011845; DOI: 10.1212/WNL.0000000000011845

Alex Delaney-Gesing

Articles

Bausch + Lomb announces topline results for phase III trial of NOV03 to treat DED associated with MGD

Adjusting ophthalmology practice to a pandemic

Hearing and vision loss may pose high risk for dementia

Analyzing AMD in research, COVID-19-era practice